Prosthetic socket interface and assembly

ABSTRACT

A tube-sock shaped polymeric covering for wearing over an amputation stump. The covering has an open end for receiving the amputation stump and a closed end opposite the open end. The covering includes a docking means for attachment of an external device to the covering. The covering may also include one or more areas of reinforcing material that can be present in the form of a strip or rod, for example. The reinforcing material is comprised of a material that is less stretchable than the polymeric material forming the covering, and acts to reduce stretching and/or movement of the covering.

This application is a continuation of U.S. application Ser. No.11/120,251 now abandoned, filed on May 2, 2005, which is a divisional ofU.S. application Ser. No. 09/418,505, filed on Oct. 15, 1999 and nowU.S. Pat. No. 6,964,688, which is a continuation-in-part of U.S.application Ser. No. 09/131,915, filed on Aug. 10, 1998 and now U.S.Pat. No. 6,406,499, which is a continuation of U.S. application Ser. No.08/688,954, filed on Jul. 31, 1996 and now abandoned, all of which areincorporated by reference.

BACKGROUND OF THE INVENTION

The present invention relates to a gel and various articles ofmanufacture such as a cushion liner with fabric on the inside and/oroutside thereof, cushion locking liner with added-on metal threadedinsert, open-ended cushion knee or elbow sleeve, cushion fabric andcushion flat sheet all useful for increasing the comfort of the wearer.Also described is a sleeve member, and reinforced sleeve member forenclosing an amputation stump, preferably, a cushioned sock for use by,e.g., below-knee (BK) or above-knee (AK) amputees. The sleeve member andcushioning devices are preferably provided in a contoured form fitconfiguration which, when worn, comes up over the limb and adapts to aright or left side bias of the bony prominence of the residuum (stump)or are provided in simple tube (i.e., tube-sock) shape with variousoptional cushioning. Cushioning material may optionally be provided onthe inside and/or outside of the invention sleeves, liners and sheet tominimize the discomfort of, e.g., an orthotic device, such as a kneebrace, or a prosthetic device, such as an artificial arm or leg. In apreferred embodiment, the cushioning material is adjusted in thicknessand has a non-uniform thickness over the article surface. In another apreferred embodiment the sleeves and liner have cushioning material in arecessed Achilles configuration: the cushioning material does notcontact the wearer at an upper posterior (i.e., knee crease), or upperanterior (i.e., elbow crease, etc.) portion of the limb or residuum, orelbow due, e.g., to the thinning of cushioning material, even while theliner, sleeve, etc. comes up over the joint. For example, the cushioningmaterial can be thinner in these areas than in other places. In specialapplications, such as for Symes amputations, a thinner coating of gel atthe distal end of a sleeve or liner can be used.

DISCUSSION OF THE BACKGROUND

For at least the past 80 years amputees have worn tubular socks overtheir residual limb. Cotton, wool and cotton-wool blends have typicallybeen used. More recently, with the advent of synthetic materials, nylonand other textiles, including some with a measure of elasticity, havealso been utilized.

In a typical lower limb prosthesis an amputee's stump tends to “piston”in the socket: during ambulation the stump will come up in the socket ofthe prosthesis until the attaching means holding the prosthesis to thewearer cause the prosthesis to lift with the stump. On the way down, airmay be trapped between the residuum and stump sock, or between theprosthesis socket and sock, or between a socket liner and a sock.

With wool and cotton socks which tend to breathe and which are notairtight this pistoning effect is not a major problem with regard to thegeneration of sound effects. Since wool and cotton tend not to tightlyform fit a residuum, however, the amputee typically packs a materialaround the residuum once it is placed into the prosthetic device or addsadditional socks to increase thickness or puts on thicker socks in orderto provide necessary fit. However, for socks which do not breathe andwhich are made from, e.g., polymeric material, a problem occurs when theresiduum pistons in the prosthetic device: terrific sound effects suchas sucking and gurgling noises are generated which are obtrusive andinappropriate, often embarrassing the wearer. In addition, such airpockets produce non-uniform pressures and loading discontinuities on theskin, irritating it.

Finally, many amputees experience a swelling of the stump. When theresiduum is in a prosthetic socket the stump tends to contractsignificantly, and when taken out of the socket the stump tends toexpand within minutes of removal. This expansion and contraction of theresiduum contributes to the development of air pockets and thegeneration of obtrusive noises since a sock which may have provided acomfortable fit on the expanded stump becomes a loose fit with airpocket opportunities when the residuum is placed inside the prostheticsocket. In addition, and over time, an amputee's residuum tends toadjust in size, usually shrinking. As these changes occur they increasethe tendency for the pistoning effect, described above, to occur. Inaddition to the embarrassment caused by the sound effects generated bypistoning, cushioned socks which allow or promote air pocket formationquickly wear out and, if not replaced often, lead to lesions, etc. onthe residuum.

Currently available cushioned residuum socks are tubular or conical anddo not provide a form fit on an amputee's residuum. Regardless whethersuch socks are provided with internal and/or external cushioningmaterial they fail to avoid air pockets. While a stump may generallyhave a roughly conical or cubical shape there are invariably recessedareas on, e.g., the medial side of the prominent tibia bone. Generally,on a below knee, left side residual limb the recessed area will bepredominantly on the right side of the tibia bone. There is alsotypically a smaller recessed area on the left side. For right sideresidual limbs the predominant recessed area is on the left side of thebone, with smaller recessed areas on the right side. Usually, thegreatest recess occurs immediately below the patella, on either side. Inaddition, left side amputees typically have a right side bias to thebony prominence of the below knee stump, and right side amputees have asimilar bias to the left side. Conventional tubular or conical elasticsocks simply cannot account for these several variable conditionswithout using extremely high levels of elastic tension which compressthe outermost points along the stump's circumference, causing discomfortand a non-uniform fit.

Amputees typically attach a prosthetic limb to their residual limb bymeans of a rigid socket, liner, and a suspension means. The rigid socketis often custom fabricated to match the shape of the intended user'sresidual limb and may be made of thermoplastic or fiber reinforcedthermoset materials, but can also be made from wood, metal, etc. Sincesuch hard materials are generally uncomfortable when in intimate withthe skin over long periods of time, especially under load bearingconditions, liners and/or prosthetic socks are often used as interfacemembers between the hard socket and the residual limb to increasecomfort. Such liners are generally of the open cell foam type, such asPelite or Kemblo, but may also be made of silicon, urethane, etc. typematerials. See, for example, U.S. Pat. No. 5,258,037 and U.S. Pat. No.5,376,132, both incorporated herein by reference. Prosthetic socks, asmentioned above, may be made of wool, cotton, synthetic materials, etc,and amputees tend to prefer liners and socks which are easily changed tofacilitate cleaning, to accommodate volume changes in the residual limb,or to accommodate different user activities.

Suspension systems which help to hold a prosthetic limb in place may ormay not be an integral part of the rigid socket and/or liner. Examplesof suspension systems include supracondylar or waist belt, joint andcorset systems, neoprene or latex sleeves, socket ears which grip thecondyles, suction or pin and lock systems such as those where the pin isattached to a liner and the lock is attached to a hard socket, etc.Examples of typical suspension systems may be found in U.S. Pat. No.4,923,474, U.S. Pat. No. 4,923,475, U.S. Pat. No. 5,007,937, U.S. Pat.No. 5,108,456, U.S. Pat. No. 5,201,773, U.S. Pat. No. 5,201,774, U.S.Pat. No. 5,246,464, U.S. Pat. No. 5,263,923, U.S. Pat. No. 5,314,497,U.S. Pat. No. 5,387,245, U.S. Pat. No. 5,376,131 and U.S. Pat. No.5,405,405, all incorporated herein by reference.

However, and as is clear from the above description of the prior art,all current interfaces for use between an amputee's residual limb and aprosthetic device suffer from drawbacks which may include customfabrication (and corresponding long lead times), high cost, lowdurability, space requirements (too long, too high profile, etc.), noisedue, for example, to air pockets forming between the liner and theresidual limb, skin irritation, restricted joint range of motion, lackof accommodation of stump geometry changes, objectionable odors,discoloration, inadequate comfort, etc.

SUMMARY OF THE INVENTION

Accordingly, one object of this invention is to provide a gel which canbe used alone or in combination with various other materials such asfabrics and which can be used in or formed into various articles ofmanufacture, apparel, etc., and used by an amputee and nonamputee toprovide increased comfort.

Another object of the present invention is a cushion liner which can fita range of residual limb sizes with minimal or no air pockets and whichcomprises, preferably, the invention gel with or without fabric,preferably having a non-uniform thickness throughout.

Another object of the present invention is a cushion locking linersimilar to the invention cushion liner but having docking meanspreferably at the distal end or side thereof for coupling the liner toe.g., the hard socket of a prosthetic device. The docking means arepreferably molded directly into the cushion liner.

Another object of the present invention is an open-ended cushion or kneeor elbow sleeve which is open on both ends and, when worn by an amputee,can cover the residual limb and limb and prosthetic device so as toprovide increased support for the prosthetic device, or a seal for asuction suspension system, and when worn by a non-amputee providespadding or joint support or protection from environmental elements. Gelalone or fabric/gel composites in tube shape are preferred. For use as aseal the invention sleeve can be worn over invention socks, closed-endedsleeves, fitted sleeves, etc.

Another object of the present invention is to provide a cushion flatsheet which is made of gel, of gel and fabric, or of gel and anothermaterial which can be used to make any of the invention cushion liners,cushion locking liners, cushion knee sleeves, cushioned socks, etc., andwhich can be used in other applications where padding is requiredincluding shoe inserts, support bracing, seat cushions, sports pads forthe knee, shin, elbow, chest, hand, etc., crutch arm pads, etc. Theinvention cushion flat sheet can also be used as a compression wrap,etc.

Another object of this invention is to provide a novel optionallycushioned sleeve member for enclosing an amputation stump having aform-fitting tubular shape.

Another object of the present invention is to provide an optionallycushioned sleeve member having a bias pattern and contoured form fitwhich will equally accommodate a left side amputee and a right sideamputee.

Another object of the present invention is to provide a cushioned sock,liner, or locking liner having a contoured form fit shape and polymericcushioning material arranged to provide an interface between anamputee's residuum and a prosthetic device.

Another object of the present invention is to provide a non-cushionedsleeve member having a contoured form fit.

Another object of the present invention is to provide a cushioned sock,liner, or locking liner having a contoured form fit shape and polymericcushioning material arranged to provide an interface between anamputee's residuum and a prosthetic device.

Another object of the present invention is to provide a non-cushionedsleeve member having a contoured form fit.

Another object of the present invention is to provide a cushioned sleevemember for enclosing an amputation stump having a contoured,form-fitting tubular shape wherein, preferably, the interior of theclosed end of the sleeve member which if fabric, is impregnated with orcoated with a polymeric material arranged in a recessed Achillesconfiguration which provides a cushioning effect at the interfacebetween the residuum and a prosthetic device socket but which minimizesor eliminates contact with the skin in the crease of the knee or elbowor ankle, even while coming up over those joints when worn. Theform-fitting sleeve member can be made of invention gel only orthermoplastic only also while still having a recessed Achillesconfiguration.

Another object of the present invention is to provide a cushionedsleeve, open-ended sleeve, sock, liner or locking liner which allows forthe timed-release of a skin conditioner, biocide, etc.

Another object of the present invention is to provide a cushioned sleevefor an amputation residuum which is form fitting and which avoids thegeneration of air pockets and the obtrusive noises they provide.

Another object of the present invention is to provide a sleeve memberfor enclosing an amputation stump which is form fitting and which isoptionally cushioned, which is as thin as possible.

Another object of the present invention is to provide a sock, includingtypical prior art tube socks, etc., having cushioning material on theinside thereof in a recessed Achilles configuration.

Another object of the present invention is a reinforced sleeve member,cushion liner, cushion locking liner, knee sleeve, and all otherinvention articles, having a reinforcing material at, e.g., the distalend thereof or in any other location desired such as stress points,surfaces subjected to abrasion, etc.

Another object of the present invention is a cushion liner with fabricon both the inside and outside surfaces thereof.

Another object of the present invention is the provision of a seal onthe exterior and/or interior of all invention articles, preferably theinvention cushion liner, wherein the fabric or gel surface of aninvention sock, sleeve, etc., is provided with an elastic,air-tight-forming seal in the form of a band, etc. on the outside and/orinside thereof. The seal is preferably made of the invention gel,silicone, thermoplastic, etc.

Another object of the invention is to provide a cushioned fabric whichcan be used to form any article that contacts the body.

Another object of the invention is to provide a sleeve member which ispredominately longitudinally stretchable in the area adapted to coverthe knee of a wearer and is predominately circumferentially stretchableabove, below, and behind the knee.

Another object of the invention is to provide a sleeve member having athicker, higher wear resistant elastic fabric in the front and athinner, higher elastic fabric in the back.

Another object of the invention is to provide a sleeve member withlongitudinally extending boning or stays along the lateral sides thereofto assist in retaining the sleeve in position on the leg of a wearer.

Another object of the invention is to provide a sleeve member oropen-ended tube sock-shaped member with an elastic band or otherfinishing around an open end of the member to assist in retaining themember in position on the leg of a wearer.

Another object of the invention is to provide a liner or open-ended tubesock-shaped member having a thicker, higher wear resistant elasticfabric at the front and bottom thereof and a thinner, higher elasticfabric at the back thereof.

Another object of the invention is to provide a liner or open-ended tubesock member with a thicker, higher wear resistant elastic fabric at thebottom thereof with the remainder of the member being formed from afabric for which wear resistance and comfort are sufficient.

Another object of the invention is to provide a gel with athermal-regulating additive for absorbing and/or releasing heat.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete appreciation of the invention and many of the attendantadvantages thereof will be readily obtained as the same becomes betterunderstood by reference to the following detailed description whenconsidered in connection with the accompanying drawings, wherein:

FIGS. 1 a and 1 b show a typical pattern for the reflected two-pieceform fitting sleeve member according to the invention.

FIG. 2 a shows a frontal view and FIG. 2 b shows a side view of theinvention sleeve member enclosing a stump-like form, where 1 a and 1 brefer to the pattern members of FIGS. 1 a and 1 b, respectively.

FIGS. 3 a, b, and c show a typical pattern for the optionally bandedthree-piece form fitting sleeve member according to the invention, thepiece of FIG. 3 a being optional. Piece The piece of FIG. 3 a can alsobe used the pattern of FIGS. 1 a and 1 b to provide a top band.

FIG. 4 shows an invention sleeve member assembled from the FIG. 3pattern, where a, b and c correspond to patterns a, b and c,respectively, in FIG. 3.

FIG. 5 shows a cushion liner according to the present invention withuniform wall thickness.

FIG. 6 shows a cushion liner according to the invention having a taperedwall thickness at the open end.

FIG. 7 a shows a side view and FIG. 7 b shows a front view of aninvention cushion liner which has a contoured inner surface providingvariable thickness cushioning material at portions of the liner intendedto provided particular selective cushioning to the user.

FIG. 8 shows an invention open-ended cushion knee or elbow sleeve withoptional fabric covering and with optional thinning at both ends.

FIG. 9 shows an invention locking liner with docking means at the distalend thereof.

FIG. 10 shows an invention form fitting sleeve having an optional windowof clear plastic material, etc., in the fabric.

FIG. 11 shows an invention open-ended knee or elbow sleeve in positionand contacting a cushion liner and a prosthetic device.

FIG. 12 shows a cushion locking liner with reinforcement. The threadedinsert is molded in.

FIGS. 13( a) and 13(b) illustrate a sleeve wherein the fabric over theknee is stretchable primarily in the longitudinal direction of thesleeve and the remaining fabric above and below the knee and at the backof the leg is primarily stretchable in the radial direction asillustrated by the double ended arrows in FIGS. 13( a) and 13(b).

FIG. 14 illustrates a sleeve which comprises a thicker, higher wearresistant elastic fabric in front of the wearer's leg, highly elasticthinner material at the back of the wearer's leg, and longitudinallyextending boning or stays along the lateral sides of the sleeve.

FIG. 15 illustrates a thicker, higher wear resistant fabric in the frontportion of the sleeve, highly elastic thinner fabric in the back of thesleeve, and continuous longitudinally extending boning or stays on thelateral sides thereof.

FIG. 16 illustrates a sleeve having an elastic band sewn adjacent thetop of the sleeve.

FIG. 17 illustrates a U-shaped elastic band positioned over the top edgeof the sleeve and sewn thereto.

FIG. 18 illustrates a sleeve wherein the top edge of the sleeve isfinished with an overlock stitch.

FIG. 19 illustrates a sleeve provided with loops adjacent the top edgethereof adapted to retain an elastic strap.

FIG. 20( a) illustrates a liner or tube sock-shaped covering wherein thefront portion is made of a thicker, higher wear resistant elastic fabricand the rear portion comprises thinner elastic fabric for more comfortbehind the knee.

FIG. 20( b) is another embodiment of a liner or tube sock-shapedcovering illustrating a thicker, higher wear resistant fabric at thefront and thinner, higher elastic fabric for more comfort behind theknee.

FIG. 21 (a) illustrates a four part liner or tube sock-shaped coveringwherein the bottom two parts, one at the front and one at the back, aremade of a thicker, higher wear resistant fabric and the two upper parts,one at the front and one at the back, are made of a thinner fabric forwhich wear resistance and comfort are sufficient.

FIG. 21( b) illustrates a three part liner or tube sock-shaped coveringwherein a single bottom part of a thicker, higher wear resistant fabricextends from the front around to the back and is attached to two upperparts, one at the front and one at the back, made of a thinner fabricfor which wear resistance and comfort are sufficient.

FIG. 22 illustrates a two part liner or tube sock-shaped coveringwherein a single front part of a higher wear resistant fabric isattached to one or more of parts of thinner fabric which covers thebottom and back.

FIG. 23 illustrates a liner with an annular ring interfacing with aprosthetic socket.

FIG. 24( a) illustrates a liner with an annular ring interfacing with aprosthetic socket lined with another gel liner.

FIG. 24( b) illustrates three sample profiles for the annular ring ofFIG. 24( a).

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENT(S)

U.S. application Ser. Nos. 08/406,145 and 08/611,305 are incorporatedherein by reference. The present invention polymeric gel compositioncomprises, preferably, a block copolymer and, optionally, mineral oil.The gels of the invention are nonfoamed or foamed with, e.g., a foamingagent. The mineral oil may be present in from 0-95% by weight based ontotal gel weight, more preferably 70-90% by weight, but also includingall of any positive amount including 5, 10, 15, 20, 25, 30, 35, 40, 45,55, 60, 65, 70, 75, 80, 85, and 90% by weight and all values and rangesin between all these listed values. The invention gel preferably has adurometer (Shore A) of 0-20 and preferably a durometer that matches orapproximates (±10%) human skin. Preferably, the oil is present on anequal weight basis, or in a weight ratio of 1/4, with regard to theamount of polymeric material present. More preferably, the gel durometeris from 1-100 Shore 00, most preferably 5-35. The polymeric materialpresent is preferably a styrene isoprene/butadiene block copolymer orstyrene-ethylene/butadiene-styrene block copolymer. Preferable examplesof such polymeric materials useful herein include C-Flex 1970-W5(R70-339-000), C-Flex 1960-W5 (both manufactured by Consolidated PolymerTechnologies, Largo, Fla., U.S.A.), Kraton G1654 (manufactured by ShellChemical Co.), Septon 4033, 4044, 4055, 4077, and 4099 (manufactured byKuraray), DYNAFLEX G6703, G6708, G6713 and G2706 (manufactured by GLSCorp.). For the C-Flex materials a particularly preferred ratio is 1part oil per 2 parts C-Flex material.

Preferred ratios of polymer to mineral oil are 1/1-4/1 using C-Flex1970-W5 or 1960W5, one part Kraton G1654:2.75 parts mineral oil, and 14parts Kraton G1654:15 parts CFlex R70-306 (or R70-190 or R70-251 or anymixture thereof): 40 parts mineral oil. The CFlex R70-339-000, R70-306,-190 and -251 materials are also preferred herein and are products ofConsolidated Polymer Technologies. They are blends of S-EB-S blockcopolymer or SIB block copolymer with mineral oil. 10 parts Kraton G1654and 11 parts CFlex R70-306 and 27 parts Duoprime 70 oil is alsopreferred. A highly preferred gel is 62.5% C-Flex 1970-W5, and 37.5%Carnation mineral oil. 55-65% C-Flex 1970-W5 and 45-35% oil is alsopreferred. Also preferred is a composition of 26-65 wt %styreneisoprene/butediene block copolymer and 35-74% by weight mineraloil. Here, 27, 28, 29, 30, 35, 40, 45, 50 and 55 wt % SIB can be usedwith oil ranging from 73, 72, 71, 70, 65, 60, 55, 50 and 45 wt %. All%'s are percent by weight unless otherwise indicated.

The preferred polymers useful herein and listed above (C-Flex, Kraton,Septon, and DNYAFLEX materials), in addition to beingstyrene-isoprene/butadiene or styreneethylene/butadiene-styrene blockcopolymers (mixed with mineral oil in the case of at least the C-Flex1970-W5, R70-339-000, R70-306, -190 and -251 materials) also includestyrenebutadiene-styrene and any thermoplastic elastomer having theShore A and/or Shore 00 characteristics listed above and capable ofbeing blended with mineral oil. Mixtures of all mentioned polymers maybe used. Several preferred polymeric materials useful in all aspects ofthe present invention are more particularly described with regard to theinvention sleeve member infra.

The mineral oil used herein is preferably purified mineral oil and ispreferably USP grade. Carnation mineral oil is preferred.

The present invention cushion liner and cushion locking liner may havean overall tube-sock shape or may be form-fitting (described more fullybelow with regard to the invention sleeve member). These shapes arereferred to generically as sock-shaped coverings. The invention sleevecushion liner and cushion locking liner can fit a range of residual ornormal limb sizes with minimal or no air pockets, come up over the kneeor elbow when worn, and preferably have a range of elasticity of from10-2400% and a range of distal radius of ¾″-4″ or whatever is requiredby the wearer. The invention sleeve, open-ended sleeve, cushion linerand cushion locking liner may be made of the invention gel itself or ofa combination of gel/fabric with appropriate seaming, where necessary.At least three standard geometries may be provided for both theinvention cushion liner and cushion locking liner, those geometriesbeing 1) uniform wall, 2) tapered wall and 3) contoured wall. Thesegeometries are also useful with regard to the invention sleeve andopen-ended sleeve member discussed below and refer to the thickness ofthe gel. Recessed achilles configuration (see infra) can be used in allarticles and aspects of the invention, as can a reverse taper of gelthickness where gel is thin at the distal end and thicken towards theopen end.

The uniform wall cushion and cushion locking liner simply comprise auniform thickness of gel. Tapered wall cushion liners and cushionlocking liners are generally those having a layer of gel which isthicker distally for additional padding (and because most shrinkage ofthe residual limb occurs at this point of the limb) and thinnerproximally (near the open end of the liner) to blend in and interfacemore easily with the residual limb or vice versa for, e.g., Symesamputations. Contoured wall cushion liners and cushion locking linershave uneven distribution of gel throughout to provide cushioning effectswhere needed and, in a preferable embodiment, have a thinner posteriormiddle and upper to allow maximum range of motion optionally with athicker distal end both anterior-medial and anterior-lateral with lessthickness in the region between these two areas so as to pad typicalbony prominences. Contoured wall liners are often thicker distally andcustom shapes can easily be provided to satisfy the individual user. Forexample, in the liner of FIG. 7, the hatched area has a gel or polymericmaterial cushion thickness of 13 mm, the dotted portion 11 mm, the frontof the liner 9 mm and the portion for behind the knee less than 9 mm.

For both the invention cushion liner and cushion locking linercombinations of gel with fabric include gel with a two-piece orthree-piece form-fit sleeve (described below). Other configurationsinclude gel coating inside a tube-sock fabric form.

Foamed or nonfoamed thermoplastic elastomers or rubber only can also beused as cushioning material alone or in combination with the inventiongel in all the articles of the invention. The term “thermoplasticelastomers” has its typical meaning and excludes the invention gel.Urethanes, rubbers, thermoset elastomers such as silicones and otherpolymers can also be used. The foamed materials can exclude mineral oil.The inclusion of thermoplastic elastomers in the invention gel (themixture optionally being foamed) is advantageous in making the productscustomizable since such products will tend to take the shape of a limbor model of a limb when, e.g., heat and/or pressure are applied. In apreferred embodiment the invention gel can be foamed and used alone orin combination with fabric in all forms of the invention including thesleeve member (open-ended or closed), in the form of a tube-sock, etc.

The present invention gel and cushion devices can include athermal-regulating additive for absorbing and/or releasing heat. Thethermal-regulating additive could be included in the gel and/or thefabric. An example of a thermal-regulating additive is microcapsulesfilled with phase change material (e.g., paraffinic hydrocarbons) orplastic crystals with appropriate thermal storage properties, such asTHERMASORB® from Frisby Technologies. Such thermal-regulating additivescan cool the body when it is hot and heat the body when it is cold.Preferably, such thermal storage properties are reversible.

In addition, in the present invention articles of manufacture includingthe cushion liner, cushion locking liner, cushion knee sleeve, cushionflat sheet and sleeve member, transducers can be included therein tosense pressure, force, temperature, etc., to detect and/or transmit asignal from the residual limb to a prosthetic device, to sendmyoelectric signals, etc. In addition to transducers, any electricaldevice or other sensing device can be similarly incorporated fordetection, signal transduction, etc. See, for example, U.S. Pat. No.5,443,525, incorporated herein by reference.

As mentioned, above, the invention cushion locking liner comprisesdocking means for attaching an external device, etc., to the liner. Suchdocking means includes pins, cables, straps, Velcro® (hook and loop typefasteners), snaps, buckles, buttons, etc. and are typically those whichhelp to attach and support a prosthetic device. Some of these dockingmeans are known in the art and are preferably incorporated in thecushion locking liner by means of direct molding, meaning the molding ofan adapter into the fabric by injection, compression, etc., molding,etc., using, preferably, urethane such an 80 Shore A urethane (Smooth-OnPMC-780) after the gel is molded to the fabric. See FIG. 12. Suchdocking means, including distal inserts, can be centered or can beoffset to accommodate individual residual limb geometries. Other dockingmeans include molding a raised configuration in the side of the linerwhich then mates with a recess on the inside of the prosthetic socket,allowing for a locking effect when the user dons the liner and stepsinto a socket, as well as attaching one or more cables, etc., to theliner which are then drawn through the bottom of the socket. The abovementioned raised configuration might be in the form of one or morebosses (e.g., one on the medial side of socket and/or one on the lateralside of socket or in the form of an annular ring (see FIGS. 23 and 24).Such docking means 2 (FIG. 12) can also be used to provide additionalsuspension for a liner by connecting the proximal end of the liner orother cushioning device to a strap, belt, sleeve, etc., which attachesto the body of the wearer. One particular embodiment would be toincorporate the hook or the loop portion of Velcro® directly into thefabric sleeve by sewing or some other means and incorporating a matingpiece of hook or loop material into a strap which connects to a waistbelt. Such docking means 3 (FIG. 12) can also be used to attach pads toparts of the liner or other cushioning device to fill undesirable voids,or to improve comfort, performance, or appearance. For example, a padcould be attached with snaps to a liner in an area where the amputationstump has shrunk. Alternatively, the pad could be attached to the sidewall of the socket.

The invention open-ended cushion knee or elbow sleeve (also referred toherein as cushion knee sleeve or knee sleeve, or sleeve etc., forbrevity) is intended to be worn by an amputee and provide an interfacebetween the residual limb and a prosthetic device, and is worn externalto both or may be worn by a person whose limb is intact but desires orrequires padding or joint support. The knee sleeve is generallycylinder- or band-shaped and covered on the exterior with fabric andcoated on the inside with invention gel. The interior may be furtherlined with fabric. The sleeve can be any size but typically is from 1-25inches long including 10, 15, 16, and 20 inches, and any diameter(unstretched) such as 1-10 inches, including 2, 3½, 4 and 5 inches.Fabric may cover the middle section of the interior, or all or any partof the interior, if desired. The cushion knee sleeve itself may have aconical (i.e., tapered) shape with a smaller diameter distally thanproximally or smaller diameter distally and proximally as compared to acentral diameter so as to grip and hold the prosthetic device orresiduum at the smaller diameter end(s). The interior gel coating can bethinner at either or both of the distal and proximal end, and can bethinner or absent in the back of or whole of the middle section thereofso as to not bind in the crease of the knee or elbow when worn by theuser. It is preferred that the wall thickness of the gel be thin at theends regardless whether there is fabric covering or sandwiching the gelor whether the exterior or whole cushion knee sleeve is made simply ofgel itself. It is also preferred that the circumferential elasticity berelatively high as compared to relatively low axial elasticity.

The gel and/or thermoplastic and/or thermoset elastomer used in allinvention articles is preferably provided such that the surface thatcontacts the wearer or hard socket, etc., is substantially smooth,meaning the type of surfaces depicted in the Figures and provided byinjection molding, dip coat application, melt coating and solventevaporation coating of the gel or thermoplastic or thermoset elastomeron the fabric.

The invention cushion knee sleeve can be used in combination with theinvention sleeve, cushion liner or cushion locking liner as a means forsuspension of a prosthetic device, or can be used alone. In addition,the invention knee sleeve can have attached thereto, by molding into thegel, by attachment means such as pins, etc., an orthotic knee joint andoptional support bars such that the sleeve constitutes a knee brace.Similar arrangement may be used for elbow braces.

All the invention articles such as the (open-ended) sleeve and linerscan be provided with gel or thermoplastic on the outside thereof so asto come in contact and provide increased friction with the interior gelof the cushion knee sleeve. Such a configuration provides additionalsupport and suspension of the prosthetic device. In addition, all theinvention articles can be provided with an elastic, air-tight-formingband on the inside and/or outside which can form a seal for a suctionsuspension system.

The present invention sleeve member for enclosing an amputation stumpovercomes the problems encountered with prior art tubular or conicalsocks which are either prone to air pocket sound effects or are soconstricted as to be uncomfortable by providing a sleeve member which ismade in the shape of or from a pattern and comprises the invention gel,a textile material, combination thereof, elastomer, or textile materialwith other elastomer which provides elastic tension such that the sleevemember form fits an amputee's residuum. This combination of sleevepattern in the form of gel, or gel and textile material or textilematerial alone, etc. provides a sleeve member having a comfortable feeland avoiding the generation of obtrusive sounds which are directlytraceable to the presence of air pockets between a sleeve member and anamputee's residuum or between sleeve member and prosthetic socket.

In all aspects of the invention described herein, the elasticity of thefabric and/or gel and/or elastomeric material is preferably sufficientto accommodate the swelling or shrinkage of the residual limb typicallyexperienced by an amputee and still maintain an intimate fit. Thepreferred sleeve of the invention including form fit sleeve has enoughelastic compression to form fit a stump but is not so tight as to beconsidered a stump shrinker, as in U.S. Pat. No. 4,840,635 incorporatedherein by reference. Alternatively, invention articles can be tailoredto provide sufficient pressure to reduce swelling after amputation.

FIG. 1 depicts a typical pattern from which the present inventionform-fitting sleeve member is constructed or shaped into. The pattern isa reflected two-piece pattern, one piece of which is designed to coverthe bony prominence of a typical BK stump and come up over the knee,(FIG. 1 a) the other piece joined to the first at the edges thereof andcircumscribing the typical onset of soft tissue around the stump (FIG. 1b). The two patterns can be used to cut out two or more pieces oftextile material which are brought together such that the “X” on each ofthe patterns in FIGS. 1 a and 1 b are in contact with the “X” on theother pattern, followed by the sewing together of the edges of eachpattern in typical fashion. When the two pieces are sewn together, asleeve member is provided which has a form fitting residuum-like(tubular) shape having an open end into which an amputation stump may beintroduced, a closed end opposite to the open end, an interior and anexterior. The two-piece pattern may be cut out of the same textilematerial or different textile materials, and the two pieces of textilematerial may have the same color or different colors. The three-pieceoptionally banded reflected pattern of FIG. 3 also provides a form-fitsleeve, piece (a) being optional. While the two and three piece designare preferred because they do not require specialized equipment formanufacturing the same form fitting sleeve members can be made in asingle piece with knitting equipment or by molding with a polymericmaterial such as the invention gel, thermoplastic, etc. In the case of aproduct made of invention gel alone, thermoplastic alone or combinationthereof, the gel is shaped into the patterns depicted in FIGS. 1 and 3by art-accepted means using molds, etc.

The form fit sleeve of the invention can be made from fabric, gel,elastomer, and combinations thereof according to the patterns in FIG. 1or FIG. 3. In FIG. 1 a the distance A-B divided by the distance B-Cgenerally varies from 2/1 to 1/2 and is preferably about 1/1. The widthof the pattern in FIG. 1 a at point B divided by the width at point C isgenerally approximately from 1/4-1/1, preferably about 1/2. In FIG. 1 bthe distance A-C divided by the distance B-C is generally preferablyabout 1.05-1.3, most preferably about 1.1. In both patterns of FIGS. 1and 3 the dimensions may be varied so as to provide a comfortable formfit that avoids air pockets.

The two or more pieces of textile material used to form the inventionform fitting sleeve member can be sewn together using any type of threadand any type stitch. This is also true for tube-sock shaped articles. Ina preferred embodiment, woolly nylon is used to interconnect thetwo-piece or three-piece form-fitting sleeve member of the invention orseam the tube-sock using a flat-locked stitch, which is a stitch wellknown to those in the art. This flat-locked stitch tends to create asmooth, non-irritating seam having a stretch comparable to jerseyfabric.

The size of the sleeve member according to the invention can be varieddepending upon the residuum to be enclosed by simply proportionallyreducing or enlarging the pattern, as desired. The term “form fitting”residuum-like (tubular) shape as used herein refers to the shape of theinvention sleeve member which provides a contoured fit on an amputationstump, which substantially reduces or eliminates air pockets duringpistoning of the amputation stump in a prosthetic socket and which isobtained by providing a sleeve member composed of two or more pieces offabric having the pattern described in FIG. 1 or FIG. 3 and/or comprisedof invention gel and/or other elastomeric material in the shape providedby these patterns. Residuum-like configuration is further achieved via abias molding technique that replicates contours of a normal amputationstump.

The fabric-containing articles according to the present invention may bemade with any textile material having any thickness (ply). Preferredtextile fabrics are those having elasticity, including elasticities of10-400%, such as stretchable non-wovens (e.g., the Xymid® line offabrics including Wearforce® fabrics from Xymid, LLC which connectbulkable yarns with non-woven sheet substrates), Lycra® comprisingsegmented elastomeric polyurethane fibers (spandex), supplex nylon (anengineered nylon textile fabric with a cotton-like texture andappearance), neoprene fabrics (polychloroprene fabrics), nylon,spunbonded olefin, looped nylon, spunlaced fabrics, polyester, aramidfiber fabrics, etc. However, any textile material may be used such asthose described in Textiles, fourth edition, N. Hollen et al, MacMillan,New York, 1973, The Modern Textile Dictionary, Duell, Sloan and Pearce,New York, 1963 and Dyeing Chemical Technology of Textile Fibers,Trotman, E., Charles Griffin and Co., London, 1975, all incorporatedherein by reference. The fabrics used to make the invention articles arepreferably elastic and are preferably jersey knit but include all woven,knitted and non-woven textile fabrics. In addition to those mentionedabove and described in the above-mentioned references, those describedin Volume 22, p. 762 ff and Vol. 16, p. 72 ff of the Kirk-OthmerEncyclopedia of Chemical Technology, Wiley, New York, 1983 and 1981,respectively, are also included, both of these references beingincorporated herein by reference. Mixtures of types can be used withseaming where necessary.

Preferred fabrics include mixtures of the above-mentioned fabrics, suchas a fabric of neoprene, 88% supplex nylon/12% lycra spandex, 85%nylon/15% lycra spandex, 94% polyester/6% lycra spandex. Such mixedfabrics may be uniformly mixed or may have one type of fiber orpredominantly one type of fiber on one face thereof. For example, inthose fabrics described above which contain lycra, the lycra can bemixed throughout, can make up the entire or substantially the entireface, or the entire or substantially the entire back of the fabric onceit is arranged in an invention article.

The textile fabrics used in the invention may be treated/finished in anymanner known in the art, For example, a nylon tricot surface may beapplied to the textile fabric, etc. The finishing need not be uniformover the entire invention article. The article may be selectivelytreated at, for example, above the knee (or elbow) portions, and withthe same treatment, no treatment or another treatment being presentbelow the knee or elbow. Similarly, treatment on the outer surface ofthe invention sleeve member may be different from that on the insidethereof.

The textile material used to make the invention articles is preferablyelastic (stretchable) in one or more, preferably two, directions and iscapable of adjusting to variations in form and size of the residuum orlimb. In a preferred embodiment, a nylon, neoprene, looped nyloncombination provides excellent comfort and durability. Preferredthicknesses of the invention textile material range from 0.010 in-0.200in, preferably 0.025 in to 0.125 in, all values and all rangestherebetween. Typically the thicknesses of patterns pieces in FIGS. 1and 3 are the same, but need not be.

As illustrated in FIG. 13( a) and FIG. 13( b), different materials canbe used to facilitate bending at the knee, for more comfort whilebending, and to help reduce downward movement or migration of the upperportion of the sleeve with respect to the wearer's leg during physicalactivity which includes frequent bending of the knee. Many elasticfabrics have one direction in which they will stretch more than in theother. These fabrics can be arranged such that at the thigh and at thetop of the socket (i.e., below the knee), there is a great deal ofradial stretch to accommodate different size thighs and sockets. On theother hand, at the knee area, the fabric can be rotated, as illustratedin FIG. 13( a) such that the maximum stretch is longitudinal,facilitating bending at the knee. By providing longitudinal stretch atthe knee area, there is less tendency for the upper portion of thesleeve to migrate downwardly when the knee is bent.

As illustrated in FIGS. 14 and 15, the thinner, more elastic fabrics canbe used behind the knee to reduce restriction of the knee area whilebending. The thinner and more elastic fabric behind the knee providesmore comfort. On the other hand, a thicker, higher wear resistantelastic fabric may be used at the front of the sleeve. The proportion ofthe thicker, higher wear resistant elastic fabric to the thinner, moreelastic fabric may be varied as desired. For example, as illustrated inFIG. 14, the thicker, higher wear resistant fabric may comprise about10% of the sleeve at the front thereof and the thinner, more elasticfabric may comprise about 90% of the sleeve at the back thereof. On theother hand, as illustrated in FIG. 15, the thicker, higher wearresistant elastic fabric may comprise about 90% of the sleeve at thefront thereof and the thinner, more elastic fabric comprise about 10% ofthe sleeve at the back thereof. The thicker, higher wear resistantelastic fabric also serves as an additional cushion for the knee.

In the embodiment illustrated in FIG. 14, the thicker, higher wearresistant elastic fabric comprises about 10% of the circumference of thesleeve. In that case, the 10% will be centered on the front of thesleeve so as to aid in reducing wear at the knee. The remainder of thecircumference of the sleeve would then be comprised of the thinner,highly elastic fabric centered at the back. With this combination offabrics, the resulting sleeve is highly elastic and accommodating ofvarious size thighs. In addition, the wear resistance provided by thethicker, higher wear resistant elastic fabric is mainly in the front ofthe sleeve including the knee area.

In the preferred embodiment illustrated in FIG. 15, the thicker, higherwear resistant elastic fabric comprises about 90% of the circumferenceis centered on the front of the sleeve and the thinner, highly elasticfabric comprises the remaining 10% of the circumference. The thinner,highly elastic fabric is centered on the back of the sleeve, behind theknee. In this embodiment, the sleeve has maximum wear resistance whilemaintaining an area of comfort behind the knee. Examples of the thicker,higher wear resistant elastic fabric are Wearforce™ 1541 B and 1724.Examples of the thinner, highly elastic fabric are Liberty 2252, 97785,and 98914.

The inner cuff (i.e., the reinforced area at the knee-see FIG. 8) canalso have various amounts of high wear resistant, elastic fabric infront of knee and thin, highly elastic fabric behind the knee. Theratios of high wear resistant elastic fabric to thinner highly elasticfabric in the cuff area is similar to that described above with respectto the sleeve. The preferred ratio being approximately 60-80% thicker,high wear resistant, elastic material for maximum wear protection overthe knee and approximately 20-40% thin, highly elastic material centeredin the back of the cuff area behind the knee for comfort at the knee.

The durability and performance of the sleeve can also be enhanced byfixing the sleeve to the prosthetic socket so that the inner cuff coversthe top edge of the prosthetic socket and does no move relative to thetop edge of the prosthetic socket. This can be done with adhesive,Velcro® (hook and loop type fasteners), rivets, snaps, buttons, screws,or other methods. The preferred place to make the attachment is at thecuff.

Another way to improve the wear properties and performance of a gel andcushioning device is to apply a polymer coating to the fabric in thehigh wear area, such as at the brim of the prosthetic socket or at theseams. Polymers appropriate for this purpose include epoxies orurethanes, especially those that are flexible (e.g., Smooth-On PMC-780).

Polymer or metal coatings can be used to improve properties of gel andcushioning devices related to insulation, friction, cleanliness,bonding, suspension, water resistance, etc., as well as durability.Examples of these coatings are Super Composite Skin® and Titanium Alpha®provided by Yamamoto Corporation, Osaka, Japan.

As illustrated in FIGS. 14 and 15 longitudinally extending boning orstay material may be attached to the lateral sides of the sleeve toreduce movement of the sleeve with respect to the wearer's leg and toreduce wrinkling that tends to occur at the knee. The boning or staysessentially hold the sleeve up and prevent the tendency of the sleeve tomove downwardly on the leg of the wearer. The boning or stays can be ofthe sew-through type or a sheath can be sewn to the lateral sides of thesleeve to hold the boning or stays.

The boning or stays can be flat or round. If flat they have a preferredaxis of bending. The round type can bend in any direction. The flattype, as illustrated in FIG. 14, can be attached to the sleeveimmediately above the knee and immediately below the knee, but not atthe knee. The flat type are preferably discontinuous at the knee so asto allow bending at the knee. As illustrated in FIG. 15, the round typecan be continuous at the knee because they will bend with the knee.

The stays and bones can be made of many materials including fiberglassrods or strips, plastics of many types, etc. As illustrated in FIG. 14,multiple pieces of boning or stay material can be used in parallel forincreased resistance to wrinkling and movement of the sleeve withrespect to the wearer's leg.

Edge treatment providing some type of finish, as illustrated in FIGS.16-19, help to reduce permanent deformation of the sleeve and also helpsto reduce movement of the sleeve with respect to the wearer's leg. Aband of some type of elastic fabric can be sewn to the sleeve edges asillustrated in FIG. 16. In FIG. 16, the elastic band is illustrated asbeing attached to an edge of the sleeve by zigzag stitching. In FIG. 17,a U-shaped elastic band is illustrated as being positioned over an edgeof a sleeve and attached thereto with zigzag stitching. FIG. 18illustrates a sleeve edge finished with an overlock stitch. FIG. 19illustrates a sleeve edge provided with loops adapted to retain a strapmade of elastic fabric. An elastic strap of this type can includeoverlapping ends that are easily adjusted by use of any conventionalfastening devices such as Velcro® (hook and loop type fasteners), snapfasteners, buckles, buttons, etc. On the other hand, the amputee neednot use the strap at all if he or she feels it is unnecessary. Otherforms of edged treatment could be used including any combination of theabove listed types.

FIGS. 20( a)-21(b) illustrate various tube sock-shaped coverings orliner embodiments according to the invention. Different fabrics can beused to facilitate bending at the knee and for more comfort whilebending. Different fabrics also provide for different bond strengthswith the laminated gel.

As illustrated in FIGS. 20( a) and 21(b), a thicker, higher wearresistant elastic fabric can be used at the front and a thinner, moreelastic fabric can be used behind the knee to reduce restriction of theknee area while bending. The thinner and more elastic the fabric isbehind the knee, the more comfort that is experienced by the wearer.

Fabrics with vertical fibers protruding from the weave, such asfiber-on-end fabrics have higher bond strengths with the laminated gel.These fabrics tend to be thicker and more abrasion resistant thanstandard woven and cordura fabrics, but they can have nearly identicalelastic properties. Examples of fiber-on-end fabrics include Wearforce™1541B and 1724. The proportion of the thicker, higher wear resistantelastic fabric for the front of the liner to the proportion of thethinner, highly elastic fabric for the back of the liner may vary. Thethicker, higher wear resistant fabric can comprise approximately 10% to90% of the total circumference of the liner with the thinner, highlyelastic fabric constituting the rest. In the embodiment illustrated inFIG. 20( a), where the thicker, higher wear resistant fabric comprisesabout 30% of the circumference of the liner, it is centered at the frontof the liner so as to aid in reducing wear at the knee and to providecushioning for the knee. In addition, it wraps around the distal end ofthe liner to act as an improved bonding area for the gel. The remainingapproximately 70% of the circumference of the liner is then comprised ofthe thinner, highly elastic fabric. With this combination of fabrics,the resulting liner is highly elastic and accommodating of various sizethighs, with wear resistance mainly in the thicker, higher wear area ofthe front of the liner, at the knee area.

In the preferred embodiment illustrated in FIG. 20( b), the thicker,higher wear resistance elastic fabric comprises about 70% of thecircumference of the liner and the thinner, highly elastic fabriccomprises the remaining approximately 30% with the thinner, highlyelastic material centered in the back of the liner, behind the knee. Thethicker, higher wear resistant fabric in this embodiment also wrapsaround the distal end of the liner to provide an improved area for gelbonding and to provide more cushioning for the knee. In this embodiment,the resulting liner provides maximum wear resistance and the greatestgel adhesion at the distal end of the liner while maintaining an area ofcomfort behind the knee.

In the embodiments illustrated in FIGS. 21 (a) and 21(b), a fabric ischosen for the front and back of the liner which provides suitable wearproperties and comfort characteristics. A distal fabric cap of thethicker, higher wear resistant elastic fabric of the fiber-on-end fabrictype is then utilized for greater gel adhesion at the distal end. Asillustrated in FIG. 21( a), the distal cap is made of two separate anddistinct parts secured together at the bottom. One part is secured to afront portion along its top edge and the other part is secured to a backportion along its top edge. In the embodiment illustrated in FIG. 21(b), the distal cap is made of one piece of fabric which extends aroundthe bottom of the liner and is secured along its top edge to front andback portions.

In the embodiment illustrated in FIG. 22, a fabric is chosen for theback and distal end which provides suitable wear properties and comfortcharacteristics. Thicker, higherwear resistant elastic fabric is chosenfor the front of the liner, specifically in the area where the linerwill contact the front and sides of the brim of the prosthetic socket.

The sleeve member according to the invention is preferably a cushionedsleeve member, that is a sleeve member having a form fitting shape withan open end into which an amputation stump may be introduced, a closedend opposite to said open end, an interior and an exterior, wherein theinterior at the closed end is impregnated with a polymeric materialarranged so as to provide a cushion between the amputee's residuum andany prosthetic device to be worn, attached to, etc. the residuum. Thecushioning material is preferably a polymeric material, most preferablythe invention gel and/or a thermoplastic elastomer (referred to simplyas thermoplastic herein) such as a thermoplastic rubber, siliconcontaining elastomer, etc. which provides an interface between theresiduum and a prosthetic device but which does not contact or minimallycontacts the skin at the back of the knee or elbow or ankle when worn byan amputee (recessed Achilles), even though the sleeve member, whenworn, comes past the knee or elbow and contacts the thigh or forearm.This cushioning material may also here and in other articles of theinvention be a thermoset silicone or a urethane. This cushioningmaterial is thus provided in a “recessed Achilles” arrangement whichavoids the irritation occurring in the crease behind a knee or elbowprovided by prior art cushion sleeves by thinning or eliminatingcushioning polymeric material at this location. If the form fit sleeveis to be worn by an above-knee amputee the recessed (thinned or absent)portion of the cushion material may be arranged medially at, e.g., theperineum for increased comfort. The interior of the sleeve member mayalso be lined with fabric so no thermoplastic or less thermoplasticcontacts the skin. In fact, in all thermoplastic-fabric embodimentsherein, an inner fabric liner may be used to provide afabric-thermoplastic (gel)-fabric sandwich structure. Embodiments whichcan be made of gel (thermoplastic) only can have an interior fabricliner.

In a particularly preferred embodiment of the invention, all articlesincluding the sleeve member, knee sleeve, etc. can be reinforced by anexternal and/or internal reinforcing material, in any shape desired,preferably in the shape of a tubular cap or dome, attached at any pointwhere reinforcing is desired including the distal end of inventionsleeves, the joint portion of knee and elbow sleeves, etc. Thereinforcing material is preferably less stretchable than the inventiongel and thermoplastic used in the particular invention article, and ismost preferably knitted nylon or Kevlar®. The reinforcing material isplaced on the invention articles (such as over the sleeve member end)and temporarily secured preferably by spray adhesive and permanentlysecured if desired. For example, stitching, permanent gluing, etc. canbe used, before the gel and/or thermoplastic cushioning is added. Thereinforcing material may be arranged on the inside, outside, or both, ofthe invention articles. In addition, it may constitute an integral partof the invention article, such as a section of reinforcing materialreplacing part of the gel or fabric of the invention article. In apreferred embodiment the reinforcing material is temporarily held inplace on fabric and the fabric is coated, dipped into, etc., inventiongel and/or thermoplastic to form a thin film of said gel and/orthermoplastic between the fabric and reinforcing material such that thereinforcing material may move independently to some degree.

The polymeric material which provides the cushioning effect in allaspects of this invention may be any polymeric material. Preferredmaterials other than the invention gel and those described above arethose elastomers described at pgs. 446-640 of Volume 8 of theKirk-Othmer Encyclopedia of Chemical Technology, Wiley, New York, 1979and those rubbers described in Synthetic Rubbers: Their Chemistry andTechnology, Blackley, D., Applied Science Publishers, London, 1983 andRubber Technology, Morton, M. Ed., Van Nostrand Reinhold Co., New York,1987, all three references incorporated herein by reference. Siliconesand urethanes are included. A preferred embodiment of the presentinvention sleeve member, when cushioned, includes a cushioning materialof Kraton®-type rubber material including those obtained from Shell,CPT, Kuraray, and GLS. These Kraton® rubbers arestyrene-ethylene/butylene-styrene block copolymers orstyreneethylene/propylene block copolymers or styrene isoprene/butadieneblock copolymers and are available in triblock or diblock form. See,e.g. the Kraton® Technical Bulletin from Shell Chemical Company, SC:1102-89, June, 1992, incorporated herein by reference.

The cushioning polymeric material used in the present inventioncushioned sleeve member is characterized by a certain durometer range.Durometers for the invention cushioning material preferably range from0-20 on the Shore “A” scale, and 1-100, more preferably 5-35 on theShore 00 scale. The lower the number the softer the material, typicallydue to a higher level of plasticizer. One preferred durometer range is3-14 (A scale), including all values therebetween and all rangestherebetween.

The invention polymeric cushioning material may be a blend of, e.g.,Kraton® rubbers and oils such as mineral oil, etc. including typicalstabilizers, etc. which provide an average durometer of from 0-20,preferably 3-14 (Shore A). These blends typically comprise a rubberhaving a lower durometer (0-10 on the Shore “A” scale) and a rubberhaving a higher durometer (e.g., 11-20). The blends are preferablycapable of being stretched 100% or more, preferably 400% or more beforetearing and are capable of providing a form fit to the residuum due totheir inherent elasticity. In addition, low durometer Kraton® rubbersand other materials tend to have a sticky feeling which, when present inthe polymeric cushioning material, tends to enhance the form fitabilityof the sleeve essentially by mating against the skin.

In donning those articles of the invention which, when worn, providecontact between, e.g., the invention gel, a thermoplastic material, acombination thereof, etc., with the skin and/or a prosthetic device itis preferred that the invention article be donned in a manner such thatthe polymeric material does not drag against the skin. For example, theinvention cushion liner or sleeve can be rolled before donning, and thenunrolled on the limb and/or device. In this manner, the cushioningpolymeric material encloses the limb and/or device without sliding orfriction. If the invention article has an outer textile surface, thetextile material slides against itself, providing easy action. Withregard to the open-ended sleeve described herein a particular advantageis obtained when this open-ended sleeve has an interior middle band offabric. The distal and proximal portions of the open-ended sleeve can berolled towards the middle of the sleeve, and the sleeve can be donnedwith contact between the wearer or device and fabric only. Thethermoplastic-containing portions can then be unrolled onto the wearerand/or device. In all cases, the invention articles can be taken off byreversing the above-describe processes. This aspect of the invention(easy donning and doffing) is an important advance in the art providedby the present invention. No lubricant, talcum powder, etc., isrequired, as with currently available materials. In addition, theinvention articles, regardless of their composition, can be adapted suchthat the portion thereof which will come in contact with the user'sapparel such as pant legs, shirt sleeves, etc., is fabric or coveredwith fabric such that the wearer's apparel does not stick to and bunchon the invention articles. At the same time the invention articles canbe designed to have polymeric material (gel, etc.) exposed in strategiclocations to aid suspension and maximize comfort. In the case of theknee sleeve a band of gel on the inside of each open end not only helpsto hold the sleeve in place but can also provide an air-tight seal for asuction suspension system when worn such that the lower portion covers ahard socket and the upper portion contacts the skin, an inventionsleeve, etc. In the case of, e.g., the invention sleeve member gel, etc.can be placed on the exterior for contact with a hard socket.

If desired, the present invention cushioning material may compriseantioxidants such as Vitamins A, B and C or any other antioxidantscommonly used in polymers which can weep out on a time release basis. Inaddition, skin conditioning agents may be added to the polymericmaterial of the present invention to soothe the skin during wear. Suchskin conditioners include mineral oil, baby oil, etc. which may be addedto the polymeric material prior to its application to the sleeve member.Also, astringents, biocides, medicaments, etc. may be added or appliedto the cushioning material to avoid infection or heal sores, etc.

As described above, the cushioning material of the present invention ispreferably formed in a recessed Achilles fashion on the interior of theinvention articles. Cushioning material may also be applied to theexterior. In both cases, it is preferred that the cushioning material beapplied such that it provides an interface between the amputee's stumpand a prosthetic device or provides padding and/or joint support butminimizes or eliminates contact with the skin at the back of the knee orelbow when worn. The cushioning material may be separated from the skinby a piece of fabric, by an interior sock liner, or may contact the skindirectly. Such contact with the skin can reduce sweating, etc.

While several methods may be used to apply the cushioning material tofabric, a preferred method includes the dipping of the closed end of theinvention article into molten or liquefied cushioning material at anangle of from 0° to 90°, preferably 20-500, most preferably 24-45°, withrespect to the surface of the molten or liquid cushioning material. Inthis manner, the cushioning material extends up the article from theclosed end thereof to a further extent on the side of the liner, sleeve,etc., is be positioned in front of the knee than behind the knee (e.g.,the pattern in FIG. 1 a faces forward on a BK amputee). As long as thecushioning polymeric material minimizes or eliminates contact with theskin at the back of the knee or elbow when worn while coming over thesejoints, but still provides an interface between the amputee's stump anda prosthetic device or provides joint support and/or padding, thematerial is in a recessed Achilles configuration. Preferably thepolymeric material comes up at least about ½-18, preferably ½-10, morepreferably 3-8, also preferably 10-18, also more preferably 12-16inches, including all values and ranges therebetween these severalvalues, from the closed end of the articles in front of the knee orelbow and covers the knee. The difference in height of the cushioningmaterial behind (i.e., in the crease of) the knee or elbow as opposed toin front of the knee or elbow can differ by several inches measured fromthe closed end of the article, typically from 1-15 inches, preferably1-8 includes and all values therebetween and all ranges therebetweenthese several values. In a preferred embodiment the cushioning materialis thicker at the closed end of the article than it is towards the openend.

In addition to the application of the invention gel and/or polymericcushioning material to, e.g., the sleeve member by dipping intoliquefied or molten polymeric material or painting the material on thearticle, etc., it is possible to dissolve the polymeric material in asolvent followed by application of the solvent to the article withsubsequent evaporation of the solvent. Close control of the thickness ofthe polymeric material is obtained using this method. In both the directdipping and solvent methods the article is generally spun withdistal endangling downward to provide tapered thickness while drying. In general,the thickness of the polymeric material applied to the inventionarticles in any fashion including in a recessed Achilles fashion can beany thickness to, e.g., several inches, but preferably varies from0.001-0.500 inches, preferably 0.011-0.150 inches but all values and allranges therebetween these several values, and can be substantiallynonconstant in thickness throughout. For example, the cushioningmaterial preferably may be thicker at the closed end of the sleeve(e.g., 0.125 in thick) and be tapered or feathered in decreasingthickness as the open end is approached. Such changes in thickness canbe accomplished by techniques known to those of ordinary skill in thisart and are within their skill. For example, compression molding can beused.

Another preferred method of producing the invention articles isinjection molding. The article is pulled over a core and inserted into acavity with polymeric material being injected into the cavity.

A preferred embodiment of the invention is a flat sheet of fabriccoated, and/or impregnate with thermoplastic, preferably invention gel,and having a strip of fabric on top of the gel. When the fabric(preferably looped nylon) is rectangular and a rectangular strip offabric is used on top of the cushioning material, the resulting flatsheet can be wrapped around the knee or elbow such that the large fabricpiece is on the outside, the small piece of fabric is on the inside andagainst the knee or elbow, and the gel (thermoplastic) cushioningmaterial contacts the leg or arm above the knee or elbow. The sheet canbe held in place with, e.g., Velcro® (hook and loop type fasteners).

Any piece of invention article can be made by direct molding in theintended shape or by making an invention cushioned flat sheet orcushioned fabric, cutting it into pattern, and connecting the patternsinto the desired shape by sewing, heat-bonding, bonding with adhesive,solvent bonding, etc. Such flat sheet material can be used to makearticles to fit any part of the body to provide cushioning, support,protection from environmental elements, the timed release ofconditioners, biocides, etc.

“Covering for enclosing an amputation stump” is a generic term for allarticles described herein whether made of gel, fabric, thermoplastic, orcombination. This term is descriptive and does not limit the uses ofinvention articles.

In another embodiment of the application the invention gel andgel/fabric laminates described above can be used to form any articlethat contacts the body such as a shoe orthosis, knee pad, glove, shirt,hip wader, etc.

Other features of the invention will become apparent in the course ofthe following descriptions of exemplary embodiments which are given forillustration of the invention only and are not intended to be limitingthereof.

EXAMPLES Example 1

A form-fit next-to-skin sock was prepared from an 88% supplex nylon/12%lycra spandex jersey knit fabric using woolly nylon thread and a surgedflat-locked stitch. The sock comprises two pieces of fabric, the firstpiece having the pattern described in FIG. 1 a, the second piece havingthe pattern described in FIG. 1 b.

A mixture of melted Kraton® rubbers obtained from Shell (G1652) and GCS(6705) and Duoprime® 70 oil (mineral oil) was prepared, the sewninverted sock was then placed over a mold facsimile of an amputationstump having recessed portions at what would be either side of the tibiaand dipped into the molten Kraton® blend at an angle of 24°-28° withregard to the plane of the surface of the molten Kraton® and removed.The mold was spun during drying. A form-fit cushioned stump sock wasobtained having adhered cushioning material in a recessed Achillesarrangement on the interior thereof.

Example 2

A 1/16 inch thick neoprene textile fabric with nylon tricot surfacetreatment for above the knee contact was used to prepare a three-pieceform fitting sleeve member according to the present invention using thepattern described in FIG. 3. The 1/16 inch neoprene material for thebelow the knee segment of the invention sleeve had nylon on the exteriorside and looped nylon on the interior side. The against the skin side ofthe above knee segment of the invention sleeve was neoprene whichprovided a high friction bond. This form fitting sock was dipped intomolten Kraton® (a blend of tough and soft Kraton® used in Example 1) atan angle of 24°-28° to provide a cushion material on the interiorthereof. The resultant composite sock of nylon, neoprene, looped nylonand cushioning rubber provides a durable cushioned sleeve member which,when impregnated with rubber, has an approximate thickness of ⅛ inch.

Example 3

A Polartec® 2000 stretch laminate fabric having an 85% nylon/15% Lycra®spandex face and a 94% polyester/6% Lycra® spandex back was used toprepare an invention sleeve member using the pattern described inFIG. 1. The resultant sleeve member is a formfitting tubular member forenclosing an amputation stump.

Example 4

A commercial cotton tube sock is inverted and dipped into moltenelastomer at an angle of 26° relative to the plane of the moltenelastomer. A sock having cushioning material in a recessed Achillesconfiguration is obtained.

Example 5

A 2-piece form fitting sleeve was made from a fabric containing 57%polyester, 33% nylon, and 10% lycra and was placed over a core pattern.A mixture of molten C-Flex 1970W5 (67 wt %) and Duoprime 70 mineral oil(33 wt %) was poured into a cavity and the core with sleeve was placedin the cavity to produce a cushion liner.

Example 6

A 2-piece form fitting sleeve was made of a nylon/Lycra material. Anadapter was injection molded into the closed end of the sleeve withpolypropylene. The sleeve with adapter was then inverted and placed overa core. A mixture of molten C-Flex 1970-W5 (50 wt %) and Duoprime 70mineral oil (50 wt %) was poured into a cavity and the core with sleevewas placed in the cavity to produce a cushion locking liner. Aftermolding, a pin was threaded into the adapter which was adapted to matewith a lock built into a prosthetic socket.

Example 7

One end of a tubular knitted terry stockinette was sewn closed and theopen end was slid over a core pattern. A mixture of molten C-Flex1970-W5 (57 wt %) and Duoprime 70 mineral oil (43 wt %) was poured intoa cavity and the core with stockinette was placed in the cavity. Oncethe gel had cooled, the stockinette with gel was removed and the closedend cut off to produce a cushion knee sleeve.

Example 8

A 2-piece form fitting sleeve was made from a fabric containing 83% polyand 17% Lycra. A mixture of molten C-Flex 1970-W5 (62.5 wt %) andCarnation mineral oil (37.5 wt %) was poured into a cavity and the corewith sleeve was placed in the cavity to produce a cushion liner. A metalthreaded insert was molded to the distal end of the cushion liner withurethane to produce a locking liner.

Example 9

Two 2-piece form fitting sleeves were made from a stretch fabric. Oneform fitting sleeve was placed in a cavity with the open end fixed tothe top of the cavity. The other form fitting sleeve was placed over thecore. A molten elastomer was poured into the sleeve in the cavity andthe core with the other sleeve was placed in the cavity to produce acushion liner with fabric on both the inside and outside and gel betweenthe fabric.

Example 10

A 2-piece form fitting sleeve was made from a stretch fabric and placedover a core. A knitted nylon dome was placed over the closed end of thesleeve. Molten elastomer was poured into a cavity and the core withsleeve and knitted dome was placed in the cavity to produce a cushionliner with reinforcement.

Example 11

A rectangular shaped piece of looped nylon is placed in the cavity of arectangular mold. Molten gel is poured over the looped nylon and arectangular strip of fabric is placed across the middle third of therectangular mold. The resulting flat sheet can be wrapped around a kneeso that the large piece of fabric is on the outside, the small piece offabric is against the knee, and gel contacts the leg above and below theknee. The flat sheet can be held in place on the leg with the hookportion of Velcro® (hook and loop type fasteners).

Example 12

A four-part form filling sleeve was made. The three front parts weremade of Wearforce 1541B, the upper and lower parts with the greateststretch in the circumferential direction and the middle part with thegreatest stretch in the longitudinal direction. The single rear part wasmade of Liberty 2252 with the greatest stretch in the circumferentialdirection. A mixture of molten Septon 4033 (7%), Septon 4055 (10.5%),and DuoPrime 90 (82.5%) was poured into a cavity, then a core with thesleeve was placed in the cavity. When the gel had cooled, the sleevewith gel was removed.

This application includes the subject matter of U.S. application Ser.No. 08/406,145 incorporated herein by reference. The material safetydata sheets and product brochures of the commercially-availablematerials mentioned herein are also incorporated herein by reference.

The invention articles are designed primarily for the human wearer, andthus are sized appropriately. Diameters typically vary from 1-8 inches(unstretched) and overall lengths typically vary from 1-30 inches(unstretched). Obviously, numerous modifications are available whichfall within the scope of the invention and appended claims.

What is claimed is:
 1. A prosthetic component comprising: a layer ofdurable fabric of a shape having a proximal open end for introduction ofa residual leg and a closed distal end for covering a distal end of saidresidual leg, said fabric of sufficient length to rise from said distalend of a residual leg over an entire portion of said residual leg to becovered by a prosthetic socket; and a block copolymer and plasticizingoil cushioning gel layer secured to only an inside surface of saidfabric such that said gel layer is in direct contact with a residual legand cushions said residual leg inside a prosthetic socket when saidprosthetic component is worn by an amputee, said gel absent from anouter surface of said fabric such that said prosthetic component mayreadily slide into and out of a prosthetic socket without said gelsticking thereto and such that said prosthetic component may be rolledduring donning or doffing thereof without said gel causing saidprosthetic component to stick to itself; wherein said fabric and gel areof sufficient thickness to stand alone as a sole interface between aresidual leg and a prosthetic socket; and wherein said prostheticcomponent has sufficient flexibility and elasticity to substantiallyconform to the shape of a residual leg to which it is donned while beingsufficiently tight to substantially eliminate air pockets between saidresidual leg and said gel layer.
 2. A prosthetic component according toclaim 1, further comprising a docking element secured to said fabriclayer at said distal end thereof, said docking element for coupling saidprosthetic component to a prosthetic socket of a prosthesis.
 3. Aprosthetic component according to claim 2, wherein said docking elementis molded directly to said fabric.
 4. A prosthetic component accordingto claim 1, wherein said gel layer is seamless.
 5. A prostheticcomponent according to claim 1, wherein said gel layer is thicker at aclosed end thereof than at an open end.
 6. A prosthetic componentaccording to claim 1, wherein said gel layer is unevenly distributed andresults in said prosthetic component having a thinner posterior middleand upper portion, and a thicker distal anterior medial and anteriorlateral portion.
 7. A prosthetic component according to claim 1, whereinsaid gel layer is arranged in a recessed Achilles configuration.
 8. Aprosthetic component according to claim 1, wherein said plasticizing oilis mineral oil.
 9. A prosthetic component according to claim 1, having alength from closed end to open end of from 10-25 inches.
 10. Aprosthetic component according to claim 1, wherein the overall thicknessthereof varies from 0.150-0.500 inches.
 11. A prosthetic componentaccording to claim 1, wherein said gel further includes a biocide.
 12. Aprosthetic component according to claim 1, wherein said gel furtherincludes a vitamin.
 13. A prosthetic component according to claim 1,wherein said gel has a Shore A hardness of between about 1-20.
 14. Aprosthetic component according to claim 1, wherein said gel has a Shore00 hardness of between about 1-100.
 15. A prosthetic component accordingto claim 1, wherein said fabric is a fiber-on-end fabric.
 16. Aprosthetic component according to claim 1, wherein said fabric is astretchable nonwoven.
 17. A prosthetic cushion liner for enclosing andcushioning a residual leg of an amputee while said residual leg islocated within a prosthetic socket, said cushion liner comprising: adurable fabric covering having an open proximal end for introduction ofa residual leg and a closed distal end opposite said open end forcovering a distal end of said residual leg, said fabric seamlesslycoated on only an inside surface thereof with a block copolymer andmineral oil gel composition having a hardness that approximates humanskin such that said gel composition will be in direct contact with aresidual leg and cushion said residual leg inside a prosthetic socketwhen said cushion liner is worn by an amputee in conjunction with aprosthesis, said gel absent from an outer surface of said fabric suchthat a portion of a residual leg covered by said cushion liner may bereadily slid into and out of a prosthetic socket without said gelsticking thereto and such that said cushion liner may be rolled duringdonning or doffing thereof without said gel causing said cushion linerto stick to itself; wherein said fabric and said gel composition are ofsufficient length to rise from said distal end of a residual leg over anentire portion of said residual leg to be covered by a prosthetic socketand are of sufficient thickness to allow said cushion liner to functionas a sole interface between a residual leg and a prosthetic socket; andwherein said cushion liner has sufficient flexibility and elasticity tosubstantially conform to the shape of a residual limb to which it isdonned.
 18. A cushion liner according to claim 17, further comprising adocking element secured to said fabric covering at said distal endthereof, said docking element for coupling said cushion liner to aprosthetic socket of a prosthesis.
 19. A cushion liner according toclaim 18, wherein said docking element is molded directly to said fabriccovering.
 20. A cushion liner according to claim 17, wherein said gelcomposition is thicker at a closed end thereof than at an open end. 21.A cushion liner according to claim 17, wherein said gel composition isunevenly distributed and results in said cushion liner having a thinnerposterior middle and upper portion, and a thicker distal anterior medialand anterior lateral portion.
 22. A cushion liner according to claim 17,wherein said gel composition is arranged in a recessed Achillesconfiguration.
 23. A cushion liner according to claim 17, wherein saidgel composition further includes at least one material selected from thegroup consisting of a biocide, and a vitamin.
 24. A cushion lineraccording to claim 17, wherein said block copolymer composition has aShore A hardness of between about 1-20.
 25. A cushion liner according toclaim 17, wherein said block copolymer composition has a Shore 00hardness of between about 1-100.
 26. A standalone residualleg-prosthetic socket interface in the form of a substantiallytube-shaped cushion liner, said cushion liner for enclosing at least aportion of a residual leg without any trapped air pockets when donnedand comprising: a durable fabric covering having an open proximal endfor introduction of a residual leg and a closed distal end opposite saidopen end for covering a distal end of said residual leg, said fabriccovering being between about 0.025 and 0.200 inches in thickness; and acontinuous and seamless layer of a cushioning and shape-conforming blockcopolymer and mineral oil gel composition residing on only an interiorsurface of said fabric covering such that said gel composition will bein direct contact with a residual leg and cushion said residual leginside a prosthetic socket when said cushion liner is worn by an amputeein conjunction with a prosthesis, said gel absent from an outer surfaceof said fabric such that a portion of a residual leg covered by saidcushion liner may be readily slid into and out of a prosthetic socketwithout said gel sticking thereto and such that said cushion liner maybe rolled during donning or doffing thereof without said gel causingsaid cushion liner to stick to itself, said gel composition beingbetween about 0.150 and 0.500 inches in thickness and extending fromsaid closed end of said fabric covering a sufficient length to cover anentire portion of said residual leg to be inserted into a prostheticsocket.
 27. A residual leg-prosthetic socket interface according toclaim 26, wherein the thickness of said gel composition is substantiallyuniform throughout.
 28. A residual leg-prosthetic socket interfaceaccording to claim 26, wherein said gel composition tapers uniformlyfrom a greater thickness near said closed end to a lesser thickness nearsaid open end.
 29. A residual leg-prosthetic socket interface accordingto claim 26, further comprising a docking element secured to said fabriccovering at said distal end thereof, said docking element for couplingsaid residual leg-prosthetic socket interface to a prosthetic socket ofa prosthesis.
 30. A residual leg-prosthetic socket interface accordingto claim 29, wherein said docking element is molded directly to saidfabric covering.
 31. A prosthetic assembly comprising: a prosthetic legincluding a hard prosthetic socket for receiving a portion of anamputee's residual leg; a standalone residual leg-prosthetic socketinterface in the form of a substantially tube-shaped cushion liner, saidcushion liner further comprising: a durable fabric covering having anopen proximal end for introduction of a residual leg and a closed distalend opposite said open end for covering a distal end of said residualleg, said fabric covering being between about 0.025 and 0.200 inches inthickness, and a continuous and seamless cushioning and shape-conformingblock copolymer and mineral oil gel composition layer of between about0.150 and 0.500 inches in thickness residing on only an interior surfaceof said fabric covering such that said gel composition will be in directcontact with a residual leg and cushion said residual leg inside saidprosthetic socket when said cushion liner is worn by an amputee inconjunction with a prosthesis, said gel absent from an outer surface ofsaid fabric covering such that a portion of a residual leg covered bysaid cushion liner may be readily slid into and out of said prostheticsocket without said gel sticking thereto and such that said cushionliner may be rolled during donning or doffing thereof without said gelcausing said cushion liner to stick to itself; wherein said gelcomposition extends from said closed end of said fabric covering by alength that is at least equivalent to a depth of said prosthetic socket;and wherein said cushion liner has sufficient flexibility and elasticityto substantially conform to the shape of a residual leg to which it isdonned while being sufficiently tight to substantially prevent theformation of air pockets between said residual leg and said gelcomposition layer.
 32. A prosthetic assembly according to claim 31,wherein the thickness of said gel composition of said cushion liner issubstantially uniform throughout.
 33. A prosthetic assembly according toclaim 31, wherein said gel composition of said cushion liner tapersuniformly from a greater thickness near said closed end to a lesserthickness near said open end.
 34. A prosthetic assembly according toclaim 31, further comprising a docking element secured to said fabriccovering of said cushion liner at said distal end thereof, said dockingelement coupling said cushion liner to said prosthetic socket when aliner-covered residual leg is inserted into said socket.
 35. Aprosthetic assembly according to claim 34, wherein said docking elementis molded directly to said fabric covering of said cushion liner.